Clinical Trials Register

Summary
EudraCT Number:	2010-024215-14
Sponsor's Protocol Code Number:	C25001
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2012-06-08
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2010-024215-14

A.3

Full title of the trial

A Randomized, Open-Label, Phase 3 Trial of brentuximab vedotin (SGN-35)
Versus Physician's Choice (Methotrexate or Bexarotene) in Patients With
CD30-Positive Cutaneous T-Cell Lymphoma

Sperimentazione clinica randomizzata, in aperto, di Fase 3 su brentuximab vedotin (SGN-35) verso la scelta terapeutica del Medico(metrotressato o bexarotene) in pazienti con linfoma cutaneo a cellule T CD30-positivo

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Study of Brentuximab Vedotin Compared to Physician's Choice in Patients
With CD30-Positive Cutaneous T-Cell Lymphoma

Studio di Brentuximab Vedotin in confronto alla scelta del Medico in pazienti con Linfoma Cutaneo a cellule T CD-30 positivo

A.4.1

Sponsor's protocol code number

C25001

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	MILLENNIUM PHARMACEUTICALS, INC.
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Millennium Pharmaceuticals, Inc
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Millennium, Drug Information Call Centre
B.5.2	Functional name of contact point	Drug Information Call Centre
B.5.3	Address:
B.5.3.1	Street Address	Drug Information Call Centre
B.5.3.2	Town/ city	Cambridge, Massachssetts
B.5.3.3	Post code	MA 02139
B.5.3.4	Country	United States
B.5.4	Telephone number	+1 151 07402412
B.5.5	Fax number	+1 1800 8816092
B.5.6	E-mail	medical@mlnm.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	Yes
D.2.5.1	Orphan drug designation number	EU/3/11/939
D.3 Description of the IMP
D.3.1	Product name	Brentuximab vedotin
D.3.2	Product code	SGN-35
D.3.4	Pharmaceutical form	Concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Brentuximab vedotin
D.3.9.1	CAS number	914088-09-8
D.3.9.2	Current sponsor code	SGN-35
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Methotrexate
D.2.1.1.2	Name of the Marketing Authorisation holder	Goldshield Pharmaceuticals
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	metotressato
D.3.9.1	CAS number	59-05-02
D.3.9.4	EV Substance Code	SUB08856MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2.5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Targretin
D.2.1.1.2	Name of the Marketing Authorisation holder	Eisai Ltd.
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Capsule, soft
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	bexarotene
D.3.9.1	CAS number	153559-49-0
D.3.9.4	EV Substance Code	SUB00795MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	75
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

CD30-Positive Cutaneous T-Cell Lymphoma

Linfoma Cutaneo a cellule T CD-30 positivo

E.1.1.1

Medical condition in easily understood language

A type of cancer of the immune system requiring treatment.

Un tipo di tumore del sistema immunitario che richiede trattamento.

E.1.1.2

Therapeutic area

Diseases [C] - Blood and lymphatic diseases [C15]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	LLT
E.1.2	Classification code	10011677
E.1.2	Term	Cutaneous T-cell lymphoma
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To determine ORR, lasting at least 4 months, with brentuximab vedotin in patients with CD30+ MF or pcALCL compared to that achieved with therapy in the control arm

• Determinare la percentuale di risposta generale (ORR), con durata di almeno 4 mesi, con brentuximab vedotin in pazienti affetti da MF o pcALCL CD30+ rispetto a quella ottenuta con la terapia nel braccio di controllo

E.2.2

Secondary objectives of the trial

CR rate with brentuximab vedotin compared to that achieved with therapy in the control arm

Determinare la percentuale di risposta completa (CR) con brentuximab vedotin rispetto a quella ottenuta con la terapia nel braccio di controllo

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Voluntary consent form - Male or female patients 18 years or older with diagnosis of MF or pcALCL - Histologically confirmed CD30+ disease by central laboratory assessment and pathology review - Eastern Cooperative Oncology Group (ECOG) performance status <= 2 - Female patients who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or agree to abstain from heterosexual intercourse - Male patients who agree to practice effective barrier contraception or agree to abstain from heterosexual intercourse - Clinical laboratory value as specified in protocol

- Consenso Informato volontario - Maschi o femmine di 18 anni o più vecchi con diagnosi di MF o pcALCL - Patologia CD30+ istologicamente confermata dalla valutazione del laboratorio centralizzato e revisione patologica - Eastern Cooperative Oncology Group (ECOG) performance status < o = 2 - Donne che sono in post-menopausa, rese sterili chirugicamente o che sono d'accordo di praticare 2 effettivi metodi di contraccezione o che sono d'accordo di astenersi da rapporti eterosessuali - Pazienti maschi che sono d'accordo nel praticare un metodo di contraccezione attraverso barriera o che sono d'accordo di astenersi da rapporti eterosessuali - Valori clinici di laboratorio come specificato nel protocollo

E.4

Principal exclusion criteria

- A concurrent diagnosis of systemic ALCL, other non Hodgkin lymphoma(excluding LyP) or Sezary syndrome - Patients with cardiovascular conditions specified in protocols - Patients with history of another primary malignancy not in remission for at least 3 years - Known active cerebral/meningeal disease, HIV infection, hepatitis B or Hepatitis C infection - Oral retinoid therapy for any indication within 12 weeks of study entry - Corticosteroid therapy within 4 weeks or immunosuppressive chemotherapy or any immunotherapy within 12 weeks of first dose of study drug - Female patients who are lactating or have a positive serum pregnancy test during the screening period

- Diagnosi concorrente di ALCL sistemico, altro linfoma non Hodgkin (esluso LyP) o sindrome di Sezary - Pazienti con condizioni cardiovascolari specificate nel protocollo - Pazienti con storia di un'altra patologia maligna primaria non in remissione per almento 3 anni - Patologia cerebrale/meningea attiva e nota, infezione HIV, epatite B o epatite C - Terapia con retinoidi orali per qualsiasi indicazione entro le 12 settimane dell'entrata dello studio. - Terapia con corticosteroidi entro 4 settimane o chemioterapia immunosoppressiva o qualsiasi immunoterapia etro 12 settimane dalla prima dose del farmaco in studio. - Donne che stanno allatando o che hanno avuto test di gravidanza positivo durante il periodo di screening

E.5 End points

E.5.1

Primary end point(s)

To determine the proportion of patients achieving an objective response that lasts at least 4 months

Determinare la percentuale di pazienti che raggiunge una risposta obiettiva con durata di almeno 4 mesi

E.5.1.1

Timepoint(s) of evaluation of this end point

At the end of cycles 3,6,9,12, and 15; at EOT; then every 12 weeks for a minimum of 24 months, and then every 6 months until disease progression or study closure

Alla fine dei cicli 3, 6, 9. 12 e 15; all'EoT, poi ogni 12 settimane per un minimo di 24 mesi e poi ogni mese fino alla progressione di malattia o chiusura dello studio

E.5.2

Secondary end point(s)

To determine the proportion of patients achieving complete response (CR)

Determinare la proporzione di pazienti che raggiungono la risposta completa (CR)

E.5.2.1

Timepoint(s) of evaluation of this end point

Does not have a specific timepoint

Non ha specifici timepoint

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

Yes

E.6.11

Pharmacogenomic

Yes

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Immunogenicity and biomarker analysis

Immunogenicità e analisi dei biomarker

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Australia

Brazil

Switzerland

United States

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1

Number of subjects for this age range:

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

105

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

124

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

For patients who complete 16 cycles of brentuximab vedotin, reinitiation
of brentuximab vedotin may be permitted at the joint
discretion of the sponsor and investigator. For patients who complete
48 weeks of reference theraphy, initiation of subsequent standard-ofcare
theraphy should be discussed with the study doctor.

Per i pazienti che completano i 16 cicli di brentuximab vedotin, la ripresa di brentoximab vedotin può essere permessa solo a discrezione congiunta di Sponsor e sperimentatore. Per pazienti che completano le 48 settimane di terapia di riferimento, l'inizio della seguente terapia di cura standard potrà essere discussa con il medico.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2012-06-11

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-05-15

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2018-07-06

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